PROLENE 8682HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031018891), received between Apr 26, 2024 and Sep 14, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 reports).

21 other recalls cover devices cleared under the same FDA submission (K133356); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. It was reported by the Distributor that: surgeon was suturing patient skin closed when noticed that needle at the end broke off. looked for suture needle in sterile field but was unable to find it. the suture was not found on or in the patient in x-ray image. No other details provided. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753775 ↗
• MalfunctionDec 24, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888512 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888511 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888510 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888505 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888502 ↗
• MalfunctionDec 24, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888384 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888375 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888363 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888362 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. FOUR NEEDLES DETACHED FROM THE SUTURE, AND ONE SUTURE BECAME FRAYED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888361 ↗
• MalfunctionMay 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT PER CLINICAL MANAGER, THE SUTURE HAS BEEN COMING OFF NEEDLE EASILY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICES WERE RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011784 ↗
• MalfunctionMay 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT PER CLINICAL MANAGER, THE SUTURE HAS BEEN COMING OFF NEEDLE EASILY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICES WERE RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011782 ↗
• MalfunctionApr 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM THE VISUAL ANALYSIS OF A PHOTO THAT THE PACKAGE WAS CONFIRMED AS A TAMPERING PRODUCT AND DIVERSION DUE TO SEVERAL VISIBLE ERRORS. BEFORE USE ON THE PATIENT, ON (B)(6) 2024. IT WAS REPORTED THAT THAT GLOBAL BRAND PROTECTION LATAM TEAM HAS PERFORMED A MARKET SURVEY IN VENEZUELA, IN VALENCIA, 8 DIFFERENT NON-AUTHORIZED AND SUSPICIOUS SELLERS. ALL PRODUCTS BOUGHT ARE LISTED BELOW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197116 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356. One submission often covers many models, so check the product and lot details in each record.

• Z-1515-2025 · Mar 7, 2025 · Open, Classified
  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
• Z-1096-2025 · Dec 20, 2024 · Open, Classified
  PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ca
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

…and 6 more.